An interventional study of Ocular surface optical coherence tomography in Keratoconus, Ocular Surface Disease and Pellucid Marginal Corneal Degeneration, sponsored by Boston Sight. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Boston Sight · Not applicable, Interventional, and Treatment
EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients.
The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.
Inclusion and Exclusion Criteria
The participant will be eligible to participate if the following criteria apply:
The participant would NOT be eligible to participate if at least one of the following criteria is met:
313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's enrollment of 11 is below the median of 40 across 205 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →Boston Sight is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
There is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting.
Device: Ocular surface optical coherence tomography
EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices
Central Corneal Clearance
Central corneal clearance as measured by OCT after 45 minutes of lens wear Outcome measure reports data only from the study eye.
Time frame: 45 minutes post lens application
Lens Decentration
Lens decentration after 45 minutes of lens wear (x axis) Outcome measure reports data only from the study eye.
Time frame: 45 minutes post lens application
Lens Comfort After 45 Minutes of Lens Wear
0 to 10 grading (0 = very comfortable to 10 = very uncomfortable) Outcome measure reports data only from the study eye.
Time frame: 45 minutes post lens application
Number of Participants With Lens Centration
Each study eye (one eye from each participant) was evaluated to determine if the lens was "Centered" (yes) or "Decentered" (no) on the eye after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
Time frame: 45 minutes post lens application
Number of Participants With Aligned Scleral Landing Zone
Each study eye (one eye from each participant) was evaluated to determine if the scleral landing zone was properly aligned on the eye (yes) or not properly aligned on the eye (no) after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
Time frame: 45 minutes post lens application
Lens Rotation
Lens rotation after 45 minutes of wear. Lens rotation was measured using an embedded program in the iTRACE system. The rotation data with image guided fitting with the OCT system was collected to compare with known experience with non-image guided fitting sets (the traditional fitting process), which typically rotate approximately 20-30 degrees on the eye. A lower number may indicate the manufactured lens more closely approximates the contours of the eye. Outcome measure reports data only from the study eye.
Time frame: 45 minutes post lens application
Number of Participants Achieving an Acceptable Fitting Lens
Number of participants achieving an acceptable fitting lens after 45 minutes of lens wear. All participants are reported. Outcome measure reports data only from the study eye. Is the fit acceptable for dispensing to the patient (yes) or is the fit NOT acceptable for dispensing to patient (no) as evaluated 45 minutes post lens application.
Time frame: 45 minutes post lens application
Number of Participants With Lens Movement
Number of patients with lens movement after 45 minutes of wear are reported. Lens movement (YES) means the lens is NOT appropriately fitting/settling on the eye. Lens movement (NO) means the lens is appropriately fitting/settling on eye. Outcome measure reports data only from the study eye.
Time frame: 45 minutes
Number of Participants With Adequate Lens Limbal Clearance
Each study eye (one eye from each participant) was evaluated to determine if there was adequate (yes) lens limbal clearance or inadequate (no) lens limbal clearance after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
Time frame: 45 minutes post lens application
| Milestone | Study Group |
|---|---|
| Started | 11 |
| Completed | 10 |
| Not completed | 1 |
Central corneal clearance as measured by OCT after 45 minutes of lens wear Outcome measure reports data only from the study eye.
| microns | Study Group |
|---|---|
| Central Corneal Clearance | 354.29 ± 62.68 |
Lens decentration after 45 minutes of lens wear (x axis) Outcome measure reports data only from the study eye.
| microns | Study Group |
|---|---|
| Lens Decentration | 477.89 ± 190.05 |
0 to 10 grading (0 = very comfortable to 10 = very uncomfortable) Outcome measure reports data only from the study eye.
| units on a scale | Study Group |
|---|---|
| Lens Comfort After 45 Minutes of Lens Wear | 2.29 ± 3.45 |
Each study eye (one eye from each participant) was evaluated to determine if the lens was "Centered" (yes) or "Decentered" (no) on the eye after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
| Participants | Study Group |
|---|---|
| Number of Participants With Lens Centration | 5 |
Each study eye (one eye from each participant) was evaluated to determine if the scleral landing zone was properly aligned on the eye (yes) or not properly aligned on the eye (no) after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
| Participants | Study Group |
|---|---|
| Number of Participants With Aligned Scleral Landing Zone | 3 |
Lens rotation after 45 minutes of wear. Lens rotation was measured using an embedded program in the iTRACE system. The rotation data with image guided fitting with the OCT system was collected to compare with known experience with non-image guided fitting sets (the traditional fitting process), which typically rotate approximately 20-30 degrees on the eye. A lower number may indicate the manufactured lens more closely approximates the contours of the eye. Outcome measure reports data only from the study eye.
| degrees | Study Group |
|---|---|
| Lens Rotation | 28.83 ± 24.05 |
Number of participants achieving an acceptable fitting lens after 45 minutes of lens wear. All participants are reported. Outcome measure reports data only from the study eye. Is the fit acceptable for dispensing to the patient (yes) or is the fit NOT acceptable for dispensing to patient (no) as evaluated 45 minutes post lens application.
| Participants | Study Group |
|---|---|
| Number of Participants Achieving an Acceptable Fitting Lens | 6 |
Number of patients with lens movement after 45 minutes of wear are reported. Lens movement (YES) means the lens is NOT appropriately fitting/settling on the eye. Lens movement (NO) means the lens is appropriately fitting/settling on eye. Outcome measure reports data only from the study eye.
| Participants | Study Group |
|---|---|
| Number of Participants With Lens Movement | 4 |
Each study eye (one eye from each participant) was evaluated to determine if there was adequate (yes) lens limbal clearance or inadequate (no) lens limbal clearance after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure.
| Participants | Study Group |
|---|---|
| Number of Participants With Adequate Lens Limbal Clearance | 7 |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Group | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Study Group |
|---|---|
| Mean | 58 ± 11.84 |
| Sex: Female, Male(Participants) | Study Group |
|---|---|
| Female | 4 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | Study Group |
|---|
| Region of Enrollment(participants) | Study Group |
|---|---|
| United States | 10 |
| Keratoconus(Participants) | Study Group |
|---|---|
| Count of participants | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Mar 2022, 15 months.
Results were first posted in Oct 2023, 1 year 7 months after primary completion.
Of 59 non-industry interventional studies with no phase under Keratoconus, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 54. This study's 15 months is below that.
Counting every sponsor, half of 68 studies reached it within 34 months; a quarter within 12 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston Sight